According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”
Other regulations, such as the ICH E6 Good Clinical Practice guidelines, identify the Case Report Form (CRF) as one of the essential documents for a clinical trial. Therefore, it is imperative to understand and implement the best practices of the CRF design process. That includes making sure all the protocol-required data are collected, ensuring the design of the CRF minimizes errors, and keeping the study coordinator in their normal workflow.
It is also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that data collection is consistent, concise, and compatible, hence, the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.
This workshop will discuss the principles of good CRF design, the timing of CRF design in relation to clinical trial start-up, and the team that will contribute to the data collection recommendations. Participants will review a sample protocol and determine which CRFs will be required to collect the appropriate data. We will discuss design philosophies and rationales and apply these principles in reviewing CRFs to critique design. We will also discuss the resources that are utilized in determining what data collection is required and the current standards for CRF data content.
The module based on best practices for CRF design as documented in the SCDM GCDMP will provide the understanding of the expectations for purposeful CRF design.
Note: This workshop will deal with the principles and fundamentals relating to data elements for good CRF design. It is not intended as a training in a software application to create the CRF.
- Identify data requirements/CRFs based on protocol review
- Evaluate the rationale for consistency in data collection
- Discuss CDASH standards for data collection in CRFs
- Identify data compatibility issues and solutions to ensure appropriate data integration
- List the “best practices” for CRF design
- Case Report Form Designers
- Clinical Data Managers
- Clinical Research Associates
- Project Managers
Denise G. Redkar-Brown, MT
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Day One: 9:00 a.m. – 4:00 p.m. Eastern (Lunch Break will run from approximately 12:00 - 1:00 p.m.)
- CRF Definition, Purpose, Considerations
- Best Practices in CRF Design
- External Data Integration
- Learners should bring a case study to describe the CRF design process in their environment, and be prepared to discuss pitfalls or success stories based on their experiences
- Review GCP Guideline ICH E6 and two sample CRFs (provided). Based on what they have read, learners will make the necessary amendments to the CRF to ensure compliance with these guidelines
- Review the sample protocol and schedule of events, and prepare a list of the CRFs which will be required for this study
- Take the Sample Standard CRF Specifications document and amend according to the sample protocol provided
- Utilize the sample protocol and schedule of events to “design” Efficacy CRFs required by the protocol (Spirometry Testing, ABECB Symptom Assessment, or Evaluation of Clinical Response), and then add this form to the CRF Specification that was completed in the previous exercise
- Students will review the CDASH document and prepare a rationale document that they can use to “convince” their management that the CDASH initiative will be beneficial for their company
$800 by Early Bird Deadline noted in Upcoming Courses section above
$1,000 after Early Bird Deadline
This course is for individual registrants only and does not allow for group training. All participants are eligible for "Certificates of Attendance," and accreditation, provided that accreditation requirements are met.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 6 hours (0.6 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-014-L01-P. Released: 2/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.